HOT FLASH RESCUE- capsicum annuum, pulsatilla pratensis, sanguinaria canadensis spray

Hot Flash Rescue by

Drug Labeling and Warnings

Hot Flash Rescue by is a Homeopathic medication manufactured, distributed, or labeled by Peaceful Mountain, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

(in each spray): 0.33% of Capsicum Annuum 3X, Pulsatilla (Pratensis) 4X, Sanguinaria Canadensis 3X.

INDICATIONS:

May temporarily relieve menopausal disorders including flushes of heat, heavy menses with pain in left ovarian region and burning palms and soles. **

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

For external use only. If pregnant, breast-feeding,taking birth control or on hormone replacement therapy, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

When using this product  Do not get into eyes.

Stop use and ask a doctor if  Condition worsens - Symptoms last more than 7 days.

This product is not intended as an alternative hormone therapy.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Apply daily to neck, chest, abdomen, inner arms or inner thighs. Use as needed.

INDICATIONS:

May temporarily relieve menopausal disorders including flushes of heat, heavy menses with pain in left ovarian region and burning palms and soles. **

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

Water, Wild Yam (Dioscorea Villosa) Root, Black Cohosh (Actaea Racemosa) Root, Chaste Tree (Vitex agnus-castus) Fruit, Lavender (Lavandula angustifolia) Buds, Sage (Salvia officinalis) Leaf, Ascorbic Acid, St John’s Wort (Hypericum Perforatum) Aerial Parts, Purified Water, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Aloe Barbadensis Leaf Juice, Tocopherols (soy), Natural Plant Extract, Potassium Sorbate, Ethanol, Citric Acid.

QUESTIONS:

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

no animal testing

PACKAGE LABEL DISPLAY:

peaceful mountain

THE HEIGHT OF HEALTH

hot flash rescue

homeopathic spray

soothing mist

2 fl. oz. (59 ml)

INGREDIENTS AND APPEARANCE

HOT FLASH RESCUE 
capsicum annuum, pulsatilla pratensis), sanguinaria canadensis spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43846-0081
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSICUM	3 [hp_X]  in 1 mL
PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (PULSATILLA PRATENSIS WHOLE - UNII:8E272251DI)	PULSATILLA PRATENSIS WHOLE	4 [hp_X]  in 1 mL
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	3 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OREGANO (UNII: 0E5AT8T16U)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)
BLACK COHOSH (UNII: K73E24S6X9)
CHASTE TREE FRUIT (UNII: 433OSF3U8A)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
SAGE (UNII: 065C5D077J)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43846-0081-1	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/18/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/18/2021

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43846-0081) , api manufacture(43846-0081) , label(43846-0081) , pack(43846-0081)